AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS

Status: Recruiting
Location: See all (190) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 12 to \<18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.

• Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:

‣ 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;

⁃ 50 to 64 years of age with at least two risk factors;

⁃ 65 to 74 years of age with at least one risk factor;

⁃ For participants 75 years of age or older, there are no requirements related to risk factors.

• The list of risk factors includes:

• BMI ≥30 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.

• Confirmed SARS-CoV-2 infection as determined by RAT in nasal specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.

• Participants must be unable or unwilling to take nirmatrelvir/ritonavir.

Locations
United States
Arkansas
Applied Research Center of Arkansas
RECRUITING
Little Rock
California
National Institute of Clinical Research - Bakersfield
RECRUITING
Bakersfield
310 Clinical Research
RECRUITING
Inglewood
Long Beach Research Institute
RECRUITING
Long Beach
Downtown L.A. Research Center, Inc.
RECRUITING
Los Angeles
Clinica mi Salud by Focil Med
RECRUITING
Oxnard
FOMAT Medical Research
RECRUITING
Oxnard
Acclaim Clinical Research
RECRUITING
San Diego
Tweedy Medical Group - Charity Health
RECRUITING
South Gate
Breathe Clear Institute for Sinus and Allergy Relief
RECRUITING
Torrance
Clinical Research of California
NOT_YET_RECRUITING
Walnut Creek
Clinical Research of California
RECRUITING
West Hills
Colorado
Paradigm Clinical Research, LLC
RECRUITING
Wheat Ridge
Washington, D.c.
Emerson Clinical Research Institute
RECRUITING
Washington D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Florida
Innovative Research of West Florida
RECRUITING
Clearwater
Invictus Clinical Research Group
RECRUITING
Coconut Creek
Hillcrest Medical Research
RECRUITING
Deland
Hillcrest Medical Research LLC
RECRUITING
Deland
Universal Axon Clinical Research, LLC
NOT_YET_RECRUITING
Doral
Herco Medical and Research Center Inc
RECRUITING
Flagami
Proactive Clinical Research,LLC
NOT_YET_RECRUITING
Fort Lauderdale
Qway Research LLC
RECRUITING
Hialeah
Sunbright Health Medical Centers
RECRUITING
Homestead
Bio-Medical Research LLC
RECRUITING
Miami
Kendall South Medical Center
RECRUITING
Miami
Nuovida Research Center
NOT_YET_RECRUITING
Miami
Global Health Research Center, Inc.
RECRUITING
Miami Lakes
Adult Medicine of Lake County, Inc.
RECRUITING
Mt. Dora
Innovation Medical Research Center
RECRUITING
Palmetto Bay
DBC Research USA
NOT_YET_RECRUITING
Pembroke Pines
GCP Research, Global Clinical professionals
RECRUITING
St. Petersburg
Global Health Research Center - Tampa
RECRUITING
Tampa
Georgia
Javara - Privia Medical Group Georgia - Fayetteville
RECRUITING
Fayetteville
Coastal Heritage Clinical Research
RECRUITING
Hinesville
Velocity Clinical Research, Savannah
RECRUITING
Savannah
Illinois
Koch Family Medicine
RECRUITING
Morton
AMR Clinical
RECRUITING
Oak Brook
Kentucky
UL International Travel Clinic
RECRUITING
Louisville
University of Louisville Hospital
RECRUITING
Louisville
University of Louisville School of Medicine
RECRUITING
Louisville
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Maryland
Centennial Medical Group
RECRUITING
Columbia
Jadestone Clinical Research
RECRUITING
Silver Spring
Michigan
Revival Research Institute, LLC
RECRUITING
Dearborn
Henry Ford St. John Hospital
RECRUITING
Grosse Pointe Woods
Montana
Mercury Street Medical Group, PLLC
RECRUITING
Butte
North Carolina
Monroe Biomedical Research
RECRUITING
Monroe
Nebraska
Velocity Clinical Research, Grand Island
RECRUITING
Grand Island
McGill Family Practice
RECRUITING
Papillion
Nevada
Las Vegas Clinical Trials
RECRUITING
North Las Vegas
New York
Upstate Global Health Institute
NOT_YET_RECRUITING
East Syracuse
Upstate Connect Care
NOT_YET_RECRUITING
Syracuse
Montefiore Medical Center
RECRUITING
The Bronx
Prime Global Research
RECRUITING
The Bronx
Ohio
Remington-Davis, Inc
RECRUITING
Columbus
Pennsylvania
Preferred Primary Care Physicians
RECRUITING
Uniontown
Tennessee
WR-Clinsearch, LLC
RECRUITING
Chattanooga
AMR Clinical
RECRUITING
Nashville
Texas
Southwest Family Medicine Associates
RECRUITING
Dallas
Southwest Mind and Body Care
RECRUITING
Dallas
Zenos Clinical Research
RECRUITING
Dallas
Gulf Coast Clinical Research - Houston
RECRUITING
Houston
Mercury Clinical Research - Santa Clara Family Clinic
RECRUITING
Houston
Next Level Urgent Care
RECRUITING
Houston
The Crofoot Research Center
RECRUITING
Houston
Epic Clinical Research
NOT_YET_RECRUITING
Lewisville
Javara - Privia Medical Group North Texas - Stephenville
RECRUITING
Stephenville
Javara - Privia Medical Group Gulf Coast - Sugarland
RECRUITING
Sugar Land
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
RECRUITING
Tomball
Utah
Alpine Research Organization
RECRUITING
Clinton
Washington
Eastside Research Associates
RECRUITING
Redmond
Other Locations
Argentina
Equipo Ciencia
NOT_YET_RECRUITING
Buenos Aires
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
RECRUITING
San Miguel De Tucumán
Belgium
ANIMA Research
RECRUITING
Alken
Pneumocare
RECRUITING
Erpent
Brazil
Infection Control
NOT_YET_RECRUITING
Belo Horizonte
CECIP - Centro de Estudos do Interior Paulista
NOT_YET_RECRUITING
Jaú
Instituto Atena de Pesquisa Clinica
NOT_YET_RECRUITING
Natal
Irmandade da Santa Casa de Misericórdia de Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Hospital Universitario Professor Edgard Santos
NOT_YET_RECRUITING
Salvador
Faculdade de Medicina do ABC
RECRUITING
Santo André
Centro de Referência e Treinamento DST/AIDS
NOT_YET_RECRUITING
São Paulo
Instituto de Infectologia Emilio Ribas
NOT_YET_RECRUITING
São Paulo
Bulgaria
Medical Centre Asklepiy
RECRUITING
Dupnitsa
Medical Center Pulmo - 2018 EOOD
RECRUITING
Haskovo
Diagnostic Consultative Center - 1 Lom EOOD
RECRUITING
Lom
MHAT Rahila Angelova Pernik
RECRUITING
Pernik
Diagnostic Consultative Center Sveti Georgi Plovdiv
RECRUITING
Plovdiv
Medical Center Sveti Ivan Rilski Chudotvorets - 2010
RECRUITING
Plovdiv
MHAT Samokov
RECRUITING
Samokov
Diagnostic Consultative Center - 1 - Sevlievo EOOD
RECRUITING
Sevlievo
Ambulatory for Individual Primary Medical Care - Dr. Pavlina Petrova - Poli ET
RECRUITING
Sofia
Medical Center Hera EOOD
RECRUITING
Sofia
Military Medical Academy
NOT_YET_RECRUITING
Sofia
SHATPD Troyan
RECRUITING
Troyan Municipality
Medical Center Diana Med 2001
RECRUITING
Yambol
Canada
Diex Recherche Quebec
RECRUITING
Québec
Clinical Research of Ontario
RECRUITING
Scarborough Village
Vancouver Infectious Diseases Centre
RECRUITING
Vancouver
Community Care Building
RECRUITING
Winchester
Dundas Manor Nursing Home
RECRUITING
Winchester
Winchester District Memorial Hospital
RECRUITING
Winchester
China
Beijing Ditan Hospital Capital Medical
NOT_YET_RECRUITING
Beijing
Peking University People's Hospital
NOT_YET_RECRUITING
Beijing
The People's Hospital of Chizhou
NOT_YET_RECRUITING
Chizhou
ZhuJiang Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Huashan Hospital, Fudan University
NOT_YET_RECRUITING
Shanghai
First Affiliated Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
Zhongshan Hospital Fudan University (Xiamen Branch)
NOT_YET_RECRUITING
Xiamen
Zhongshan Hospital Xiamen University
NOT_YET_RECRUITING
Xiamen
Finland
FVR, Etelä-Helsingin rokotetutkimusklinikka
RECRUITING
Helsinki
MeVac - Meilahti Vaccine Research Center
RECRUITING
Helsinki
FVR, Oulun rokotetutkimusklinikka
RECRUITING
Oulu
FVR, Tampereen rokotetutkimusklinikka
RECRUITING
Tampere
Germany
zibp GmbH
RECRUITING
Berlin
Praxis am Ebertplatz
NOT_YET_RECRUITING
Cologne
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio
RECRUITING
Frankfurt Am Main
Praxisgemeinschaft Heimeranplatz
RECRUITING
Munich
Studien Rahman & Detho
RECRUITING
Obertshausen
Japan
Fukuwa Clinic
RECRUITING
Chuo-ku
Shonan Fujisawa Tokushukai Hospital
RECRUITING
Fujisawa
Tashiro Endocrinology Clinic
RECRUITING
Fukuoka
National Hospital Organization Okinawa Hospital
RECRUITING
Ginowan
Terada Clinic Respiratory Medicine & General Practice
RECRUITING
Himeji
Yoshijima Hospital
RECRUITING
Hiroshima
Shonan Kamakura General Hospital
RECRUITING
Kamakura
Kamezawa Clinic
RECRUITING
Kasugai
Musashino Emergency Hospital
RECRUITING
Kodaira-shi
Koga General Hospital
RECRUITING
Koga
Rakuwakai Otowa Hospital
RECRUITING
Kyoto
Swing Nozaki Clinic
RECRUITING
Musashino-shi
International University of Health and Welfare Narita Hospital
RECRUITING
Narita
Medical Corporation Kouhoukai Takagi Hospital
RECRUITING
Okawa-shi
Nishioka Hospital
RECRUITING
Sapporo
Tsuchiura Beryl Clinic
RECRUITING
Tsuchiura
Mexico
JM Research SC
NOT_YET_RECRUITING
Cuernavaca
Arké SMO S.A de C.V
NOT_YET_RECRUITING
Veracruz
Republic of Korea
Korea University Ansan Hospital
NOT_YET_RECRUITING
Ansan-si
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Incheon Medical Center
NOT_YET_RECRUITING
Donggu
Chung-Ang University Hospital
RECRUITING
Dongjak-gu
Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
Gangnam-gu
Chonnam National University Hospital
RECRUITING
Gwangju
Gachon University Gil Medical Center
RECRUITING
Namdong-gu
Hallym University Kangnam Sacred Heart Hospital
RECRUITING
Seoul
Korea University Anam Hospital
NOT_YET_RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
NOT_YET_RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Slovakia
AMB4YOU s.r.o.
RECRUITING
Hlohovec
Artromac n.o.
NOT_YET_RECRUITING
Košice
IRS - Medicinska cinnost s.r.o., Vseobecna ambulancia pre dospelych
RECRUITING
Kosice-juh
ML MED, s.r.o., Vseobecna ambulancia pre dospelych
RECRUITING
Moldava Nad Bodvou
SALUBER SK s.r.o., Vseobecna ambulancia pre dospelych
RECRUITING
Nové Mesto Nad Váhom
PULMO, s.r.o., Pneumologicko-ftizeologicka ambulancia
RECRUITING
Prešov
MUDr. Viliam Cibik, PhD., s.r.o.
RECRUITING
Pruské
Plucna ambulancia Hrebenar, s.r.o., Pneumologicko-ftizeologicka ambulancia
RECRUITING
Spišská Nová Ves
VL.AK s.r.o. Vseobecna ambulancia pre dospelych
RECRUITING
Trnava
South Africa
Langeberg Clinical Trials
NOT_YET_RECRUITING
Cape Town
TREAD Research
RECRUITING
Cape Town
Dr P J Sebastian Clinical Research Centre
RECRUITING
Chatsworth
Synapta Clinical Research Centre
RECRUITING
Durban
Newtown Clinical Research
RECRUITING
Johannesburg
Paarl Research Centre
RECRUITING
Paarl
Global Clinical Trials
RECRUITING
Pretoria
Jongaie Research
RECRUITING
Pretoria West
Sandton Medical Research Centre
RECRUITING
Sandton
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña
NOT_YET_RECRUITING
A Coruña
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Vithas Xanit Internacional
RECRUITING
Benalmádena
Hospital Vithas Xanit Internacional
RECRUITING
Benalmádena
Hospital Universitario Reina Sofia
NOT_YET_RECRUITING
Córdoba
Hospital Universitario Infanta Leonor
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Virgen de Valme
RECRUITING
Seville
CHUVI- Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Taiwan
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
Taichung Veterans General Hospital
RECRUITING
Taichung
Taipei Veterans General Hospital
RECRUITING
Taipei
Tri-Service General Hospital
RECRUITING
Taipei City
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
Turkey
Ankara University Ibni Sina Hospital
NOT_YET_RECRUITING
Ankara
Hacettepe Universite Hastaneleri
NOT_YET_RECRUITING
Ankara
Acibadem Universitesi Atakent Hastanesi
NOT_YET_RECRUITING
Istanbul
Kocaeli Üniversitesi
NOT_YET_RECRUITING
Kocaeli
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-12-08
Estimated Completion Date: 2027-05-06
Participants
Target number of participants: 2330
Treatments
Experimental: ibuzatrelvir
Ibuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.
Placebo_comparator: placebo
placebo administered orally every 12 hours (twice daily) for 5 days.
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov